Effects of Aerobic Dance Based Exercise Program After Surgery in Obeses Awating Bariatric Surgery
1 other identifier
interventional
30
1 country
1
Brief Summary
In this study, our primary aim is; investigate the effect of aerobic dance based exercise program on lower extremity functions (walking, stair stroke climbing, etc.) in obese individuals awaiting bariatric surgery.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Nov 2019
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 14, 2019
CompletedFirst Posted
Study publicly available on registry
November 18, 2019
CompletedStudy Start
First participant enrolled
November 30, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 30, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2020
CompletedMay 11, 2022
August 1, 2020
2 months
November 14, 2019
May 10, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Six Minute Walk Test
The Six Minute Walk Test was conducted according to a standardized protocol, using an internal hallway with the 30-meter distance marked by colored tape on the floor. Participants will be told that "the purpose of this test is to see how far you can walk in six minutes." Then, they will be instructed to "walk from end to end of the hallway at your own pace, in order to cover as much ground as possible." Participants will be allowed to stop and rest during the test, but will be instructed to resume walking as soon as they were able to do so. Before the walk started and at the end of the 6-min walk, participants will be shown a modified Borg dyspnea scale printed on a card and asked to "indicate your current degree of shortness of breath" on a scale of "0 = nothing at all" to "10 = very, very severe." At the end of the walk, they will be asked if they had experienced any of the following specific symptoms: dyspnea, chest pain, light-headedness, or leg pain, or any other symptoms.
Change from baseline to 8 weeks follow up at two months and post-op 5 months
Biodex Isokinetic Muscle Strength Measurement
sokinetic device. In all cases; In accordance with the test measurement protocol, both the Quadriceps Femoris and the Hamstring muscle strength were concentric contraction, primarily 5 repetitions at 60 ° / sec; then 10 repetitions at a rate of 240° / sec. After each limb measurement, a rest interval of 2 minutes will be given. Peak torque will be recorded in Newtonmeters / kilograms (Nm / kg)
Change from baseline to 8 weeks follow up at two months and post-op 5 months
Secondary Outcomes (6)
Bioelectrical Impedance Analysis-obesity score
Change from baseline to 8 weeks follow up at two months and post-op 5 months
Biodex Balance System-Fall Risk Test
Change from baseline to 8 weeks follow up at two months and post-op 5 months
Evaluation of physical activity
Change from baseline to 8 weeks follow up at two months and post-op 5 months
Sit and Up Test
Change from baseline to 8 weeks follow up at two months and post-op 5 months
Stair Climbing Test
Change from baseline to 8 weeks follow up at two months and post-op 5 months
- +1 more secondary outcomes
Study Arms (2)
Aerobic Dance based Exercise
EXPERIMENTALThe exercise program will be administered 60 minutes, 2 days a week for 8 weeks. The exercise program will be created by physiotherapists as a group exercise program.
Counseling of physical activity
EXPERIMENTALPhysical activity counseling is aimed at increasing the physical activity levels of the individuals who are waiting for bariatric surgery in the preoperative period.
Interventions
A program consisting of aerobic dance based exercises and physical activity counseling accompanied by physiotherapists will be applied to the study group.
Only physical activity counseling will be given to the subjects in this group.
Eligibility Criteria
You may qualify if:
- Individuals aged between 18-65
- Body mass index ≥40 or ≥35 with concomitant diseases
- No surgical operation in the last 6 months
You may not qualify if:
- Musculoskeletal disorders or systemic diseases that may prevent exercise
- The presence of psychiatric or neurological disease affecting cooperation and cognitive functions
- Presence of acute pain
- Heart pain
- Presence of previous myocardial infarction, subjective heart failure, uncontrolled diabetes and hypertension
- Regular exercise for 6 months
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Istanbul University-Cerrahpaşa
Istanbul, Turkey (Türkiye)
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Gülfidan Tokgöz
Istanbul University - Cerrahpasa
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Physiotherapist
Study Record Dates
First Submitted
November 14, 2019
First Posted
November 18, 2019
Study Start
November 30, 2019
Primary Completion
January 30, 2020
Study Completion
June 30, 2020
Last Updated
May 11, 2022
Record last verified: 2020-08
Data Sharing
- IPD Sharing
- Will not share